MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 TI 3.5MM / L32MM; PLATE, FIXATION, BONE

Model Number	661432S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported that a 3.5mm axsos cortical screw broke during insertion.Additionally reported: "no screw part fell into the patient, the head of the screw broke off as it was being advanced and was still attached to the screwdriver.It was successfully removed.I could not see the angle or the pressure since he was over the fracture, he said he was just advancing it normally.There was a slight delay because he had to remove the screw from the patient which took about 5 mins.Since it was not fully advanced in the patient he was able to twist and pull the shaft of the screw out with pliers.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the two parts of the device were returned and match the reported event.The screw broke at the level of the second thread below the head.Some scratches can be noticed in the most proximal part of the longer part of the screw returned.These scratches were most probably caused during the extraction of the screw.A microscope analysis shows that the device broke in torsion, probably because of the application of an important force during insertion.This could be explained by the torsion lines that can be seen in the surface breakage.The presence of hard bone could also have contributed to the breakage.Based on investigation, the root cause was attributed to be user related.The failure was caused by an overtorque on the device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The customer reported that a 3.5mm axsos cortical screw broke during insertion.Additionally reported: "no screw part fell into the patient, the head of the screw broke off as it was being advanced and was still attached to the screwdriver.It was successfully removed.I could not see the angle or the pressure since he was over the fracture, he said he was just advancing it normally.There was a slight delay because he had to remove the screw from the patient which took about 5 mins.Since it was not fully advanced in the patient he was able to twist and pull the shaft of the screw out with pliers.".

• Brand Name: CORTEX SCREW AXSOS 3 TI 3.5MM / L32MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10467325
• Report Number: 0008031020-2020-02195
• Device Sequence Number: 19555702
• Product Code: HRS
• UDI-Device Identifier: 04546540686381
• UDI-Public: 04546540686381
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 661432S
• Device Catalogue Number: 661432S
• Device Lot Number: D34110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1